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CTRI Number  CTRI/2019/08/020535 [Registered on: 02/08/2019] Trial Registered Prospectively
Last Modified On: 30/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled parallel group study to evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BIAG-CSP-031 version 1.0, 24 Jun 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubha Rani M 
Designation  MD  
Affiliation  Sri Krishna Sevashrama Hospital 
Address  #49, 10th Main, 32 C Cross, 4th Block, Jayanagar, Bengaluru.

Bangalore
KARNATAKA
560011
India 
Phone  9449453674  
Fax    
Email  dr.shubharani111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shalini Dayananda 
Designation  General Manager 
Affiliation  BioAgile Therapeutics Private Limited 
Address  #2/5, Dahlia Building, 3rd Floor,80 Feet Road, RMV 2nd Stage,Bangalore 560094, INDIA

Bangalore
KARNATAKA
560094
India 
Phone  08043754520  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query
 
Name  Divya C 
Designation  Director 
Affiliation  BioAgile Therapeutics Private Limited 
Address  #2/5, Dahlia Building, 3rd Floor,80 Feet Road, RMV 2nd Stage,Bangalore 560094, INDIA

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
ZeusHygia LifeSciences Private Ltd. Balanagar, Hyderabad, Telangana -500037  
 
Primary Sponsor  
Name  ZeusHygia LifeSciences Private Ltd 
Address  First Floor, Plot No.47, Raviraja Industries, TechnocratsTechnocrat Industrial Estate, Balanagar, Hyderabad, Telangana -500037  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shubha Rani M  Sri Krishna Sevashrama Hospital  #49, 10th Main, 32 C Cross, 4th Block, Jayanagar, Bengaluru, Karnataka 560011
Bangalore
KARNATAKA 
9449453674

dr.shubharani111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Rheumatoid Arthritis (Knee, Hand and Neck) 
Patients  (1) ICD-10 Condition: M249||Joint derangement, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BioSOLVECurcuminTM  To be taken 2 capsules of 500 mg to be taken in morning before breakfast and at night after dinner per a day fro 12 weeks 
Comparator Agent  Placebo  To be taken 2 capsules of 500 mg to be taken in morning before breakfast and at night after dinner per a day for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients in the age group of 18-65 years, either male or female.
2.Diagnosis of RA according to the revised 2010 American College of Rheumatology (ACR) criteria (with RA functional class of II). Total number of the Swollen Joint Count (SJC) and Tender Joint Count (TJC) should be greater than 8.
3.Continuing or recurring pain (i.e joint pain daily, unless on pain medication).
4. Ability and willingness to participate in all components of the study
5. Patients who able to understand and sign written informed consent.
 
 
ExclusionCriteria 
Details  1. Patients to whom one of following applies will be excluded: dysfunction of liver; severe cardiovascular, urinary, hematopoietic, or endocrine system disease; immunodeficiency; uncontrolled infection or active gastrointestinal tract disease; recent vaccination; gravida; women in lactation period or those recently intending to become pregnant; hypersensitivity to study product; treatment with any other disease-modifying anti-rheumatic drug (DMARD) or NSAIDS within 30 days before enrolment; history of alcohol abuse; history of hyperglycemia or motor coordination disorder; or participation in other clinical trials within 3 months before enrolment.
2.Patients with any surgical procedure, including bone or joint surgery or synovectomy within 12 weeks prior to screening.
3.Patients with significant systemic involvement of secondary RA (including diseases such as vasculitis, pulmonary fibrosis or Feltys syndrome), inflammatory joint disease other than RA (e.g. gout, psoriatic arthritis, seronegative spondyloarthropathy and Lyme disease)
4. Subjects with other systemic autoimmune disorder (e.g. systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap diseases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the comparative efficacy of investigational product BioSOLVECurcuminTM by the assessment of ACR-20, WOMAC scale and VAS in patients with active rheumatoid arthritis in knees, hands and neck.  Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety of investigational product BioSOLVECurcuminTM in active rheumatoid arthritis patients.   Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90) 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/08/2019 
Date of Study Completion (India) 04/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disorder that primarily affects various body joints and causes progressive destruction of articular structures, particularly, the cartilage and bone. Notably, the joint destruction is a prominent feature of the disease that not only distinguishes RA from other arthritic diseases but also determines its outcome in the majority of individuals affected. The long-term prognosis of RA is poor with as much as 80% of patients affected becoming disabled after 20 years and a concomitant reduction in life expectancy by an average of 3–18 years. If the disease remains untreated, 20–30% of patients may become permanently work-disabled within 2–3 yr of diagnosis. Predictors of poor outcome for RA include relatively low functional disease activity scores early in the disease progression, lower socio-economic status and education level, strong family history of the disease, and early involvement of many joints. Thirty per cent of the patients with severe forms of the disease typically remain unresponsive to any classic treatment intervention. Nonetheless, patients with milder forms of the disease may derive some level of benefit from early diagnosis and treatment.

In view of the overwhelming literature and promise for the potential benefits of curcumin- induced chemoprevention and treatment of several human diseases, the current study is a pilot effort to assess the efficacy and safety of BioSOLVECurcuminTM in comparison with placebo for 12 weeks in patients with active rheumatoid arthritis in knees, hands and neck. BioSOLVECurcuminTM is a specially modified and formulated nutraceutical product with advantage of highly bioavailable curcumin for its intended pharmacological effect.

The main aim of the study is to investigate the effect of BioSOLVECurcuminTMin patients with active Rheumatoid Arthritis (RA) using subjective questionnaires as the evaluation parameters as well as assessment of the safety of the study product.


 
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